A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems (SCS MRI PMCF)

A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Procedure: MRI scan

Detailed Description

The study will be performed as an international, multicenter, prospective and single-arm design. The study will be conducted as a Post Market Clinical Follow Up (PMCF) study and the results will be submitted to the Notified Body: BSI Group (BSI).

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Wilhelminenspital Wien
• Belgium
  • Wilrijk, Belgium
    • AZ Sint-Augustinus
• Germany
  • Dusseldorf, Germany
    • Medizinische Einrichtungen der Universität Düsseldorf, Dusseldorf
  • Gera, Germany
    • Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie, Gera
• Italy
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
• Spain
  • Sevilla, Spain
    • Hospital Virgen de Rocio
• United Kingdom
  • Ykshre
    • Leeds, Ykshre, United Kingdom, LS14 6UH
      • Seacroft Hospital
• United States
  • California
    • Napa, California, United States, 94558
      • Napa Valley Orthopedic Medical Group
  • New York
    • Rochester, New York, United States, 14626
      • Unity Spine Center
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient has been implanted with a Prodigy MRI or Proclaim Elite MR conditional SCS system
• Patient will receive an MRI scan in compliance with the Instructions For Use (IFU) for the implanted MR conditional SCS system
• Patient is ≥ 18 years of age
• Patient must be willing and able to comply with study requirements
• Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form

Exclusion Criteria:

• Patient has another implanted device (active or passive) that prohibits safe scanning
• Patient has previously experienced an MRI scan-related adverse event
• Patient is currently enrolled in another Abbott study that collects MRI safety data
• Patient is incapacitated, is unable to read or write, or is pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prodigy MRI or Proclaim Elite MR; The Prodigy MRI system is only MR conditional for scans of the head and extremities (upper except shoulder, lower except hip). The Proclaim Elite system is MR conditional for scans of the head, extremities or any other body part.	Procedure: MRI scan; MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of the MRI Scan-related Adverse Events	The rate of the MRI scan-related adverse events will be assessed at 1-month follow-up.	1 month post MRI scan

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Successful MRI Mode 'Turn on' Functionality	The rate of successful MRI mode 'turn on' functionality will be assessed during pre-MRI scan.	Immediately before MRI Scan
Rate of Successful MRI Mode 'Turn Off' Functionality	The rate of successful MRI mode 'turn off' functionality will be assessed during Post-MRI Scan.	Immediately after MRI Scan
Rate of Successful 'Turn Off' Functionality for the Stimulation	The rate of successful 'turn off' functionality for the stimulation will be assessed immediately before MRI Scan.	Immediately before MRI Scan
Rate of Successful 'Turn on' Functionality for the Stimulation	The rate of successful 'turn on' functionality for the stimulation will be assessed immediately after MRI Scan.	Immediately after MRI Scan
Rate of Successful 'Turn on/Off' Functionality for the Stimulation	The rate of successful 'turn on/off' functionality for the stimulation at 1-month follow-up will be assessed.	At 1 month follow-up
Rate of Successful Adjustments to the Program	The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.	Immediately before MRI Scan
Rate of Successful Adjustments to the Program	The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.	Immediately after MRI Scan
Rate of Successful Adjustments to the Program	The rate of successful adjustments to the program will be assessed. This includes adjustments to stimulation amplitude and switch between stimulation programs.	At 1-month follow-up
Rate of Successful Interrogations and Uploads/Downloads of the Implantable Generators (IPG) Parameters	The rate of interrogations and uploads/downloads of the IPG parameters will be assessed immediately before MRI Scan. This includes establishing a link with the IPG or patient programmer and uploading and downloading of the subject's current program.	Immediately before MRI Scan
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters	The rate of interrogations and uploads/downloads of the IPG parameters will be assessed immediately after MRI Scan. This includes establishing a link with the IPG or patient programmer and uploading and downloading of the subject's current program	Immediately after MRI Scan
Rate of Successful Interrogations and Uploads/Downloads of theImplantable Generators (IPG) Parameters	The rate of interrogations and uploads/downloads of the IPG parameters will be assessed at 1-month follow-up. This includes establishing a link with the IPG or patient programmer and uploading and downloading of the subject's current program	At 1-month follow-up

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 21, 2016
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): December 2, 2020

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (ESTIMATE): April 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CRD_800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO